E7-21713. Adolescent Over-the-Counter Drug Product Use; Public Workshop

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice of public workshop; request for comments.

SUMMARY:

The Food and Drug Administration (FDA), the National Institutes of Health (NIH), and the Consumer Healthcare Product Association (CHPA) are announcing a public workshop entitled “Adolescent Over-the-Counter (OTC) Drug Product Use.” The purpose of the workshop is to gain an understanding of current use of OTC drug products by adolescents, including adolescent decisionmaking skills (compared with adult skills) and other factors influencing adolescent OTC drug product use. Information gathered at the workshop and from submitted comments will be used to identify when it would be most appropriate for consumer studies on OTC drugs to enroll adolescents, and to define the type of consumer research and study designs needed to support OTC drug product approval in the adolescent population. The workshop is intended to help inform FDA in its effort to assure the safe and effective use of OTC drug products by adolescents.

DATES:

The public workshop will be held on December 6, 2007, from 8:30 a.m. to 5:30 p.m. and on December 7, 2007, from 8:30 a.m. to 3:30 p.m. Register to make an oral presentation during the open public session by November 21, 2007. Submit written or electronic comments by January 31, 2008.

ADDRESSES:

The public workshop will be held at the Natcher Conference Center, National Institutes of Health, 45 Center Dr., Bethesda, MD 20892.

Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/​ohrms/​dockets/​ecomments.

FOR FURTHER INFORMATION CONTACT:

Faith Dugan, Center for Drug Evaluation and Research (HFD-6), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-6779, FAX: [phone], e-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

I. Introduction

We are announcing a public workshop on adolescent use of OTC drug products. OTC drugs are FDA-regulated drug products that are available without a prescription. Other health care products (e.g., dietary supplements) are beyond the scope of the workshop. Adolescents use OTC drug products from a wide range of therapeutic categories (including fluoride toothpastes, acne drug products, and pain relievers) and with varying degrees of parental oversight. While clinical and consumer behavior studies for OTC drugs have enrolled various populations, few studies have included adolescents. Therefore, limited information on adolescents' use of OTC drug products has been collected regarding the magnitude of their use, the types of products they use, factors that influence their use, or their ability to understand and follow directions provided on OTC labels.

The desire to learn more about adolescent decisionmaking skills as they relate to the use of OTC drug products has generated interest in holding a public workshop that would convene a group of scientific experts and solicit input from the public. Information gathered at the workshop would help identify methods for assessing adolescent OTC drug use and identify information useful to regulatory decisionmaking.

II. Why Are We Holding This Public Workshop?

This workshop has been developed to further our understanding of the physiological and psychological differences and similarities between adolescents and adults, which may have an impact on adolescents' decisions about OTC drug use and also may define research priorities for assessing the differences in drug use decisions. The workshop is also aimed at designing efforts to encourage appropriate OTC drug product use by adolescents. It is hoped that such efforts will foster appropriate use when adolescents become adults.

III. What Are the Topics We Intend to Address at the Workshop?

We will address the following topics at the workshop:

• OTC drug product use by adolescents;
• Discussion of adolescent neurocognitive development and decisionmaking skills;
• Discussion of how best to communicate product information directed toward adolescents;
• Discussion of future actions and research agendas, including studies regarding consumer behavioral issues; and
• Discussion of mechanisms to promote appropriate and optimal use of OTC drugs by adolescents.

We are interested in hearing comments at the public workshop or receiving written or electronic comments (see section V of this document) on the following questions:

1. What is known about current OTC drug product use by adolescents? Focus on the following information:

• Magnitude of current use of OTC drugs by adolescents;
• Product categories commonly used by adolescents;
• Market use data for such drugs;
• Consumer behavior studies that have enrolled adolescents; and
• Factors that influence adolescent's use of OTC products, such as drug class, age, parental involvement and influence, household dynamics, social circumstances, and gender.

2. How does adolescent neurocognitive development influence decisionmaking and behavior as they relate to OTC drug product use?

• Identify known factors that contribute to how adolescents make health-related decisions;
• Discuss adolescent behavior patterns, decisionmaking skills, and predictors of risk-taking behavior as they relate to purchase and use of OTC drugs; and
• Discuss differences between adolescent and adult risk perceptions and decisionmaking and discuss the ages at which identifiable developmental transitions generally occur.

3. What future actions will help promote safe and effective use of OTC drugs by adolescents?

• Discuss drug categories (e.g., analgesics, acne drugs) for which it would be appropriate to enroll adolescents in clinical and behavioral studies and identify related study design issues (e.g., design, age, informed consent, parental assent, compliance);
• Assess the need for consumer behavior studies targeted toward adolescents;
• Explore alternate and effective means of communicating with adolescents, including need for labels directed toward adolescent age groups; and
• Discuss other potential future actions to promote safe and effective use of OTC drugs by adolescents.

IV. Workshop Attendance and Registration

The Natcher Conference Center is a Federal facility with security procedures for entrance. Workshop attendees will be required to show proper identification and are asked to allow ample time to enter the NIH campus.

There is no fee to attend the workshop, and attendees who do not wish to make an oral presentation do not need to register. Seating will be on a first-come, first-served basis.

If you would like to make an oral presentation during the workshop, you must register by close of business on November 21, 2007. You must provide your name, title, business affiliation (if applicable), address, and type of organization you represent (e.g., industry, consumer organization) to Lee Lemley or Faith Dugan at 301-594-6779 (see FOR FURTHER INFORMATION CONTACT). Persons registered to make an oral presentation should check in before the workshop.

If you need special accommodations because of disability, please contact Lee Lemley (see FOR FURTHER INFORMATION CONTACT) at least 7 days before the workshop.

V. Comments

Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments regarding the issues and questions presented in this document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

VI. Workshop Transcripts

We will prepare a transcript of the workshop. The transcript will be available for review approximately 30 days after the workshop at the Division of Dockets Management (see ADDRESSES) between 9 a.m. and 4 p.m., Monday through Friday. The transcript will also be available on the Internet at http://www.fda.gov/​ohrms/​dockets.

Dated: October 30, 2007.

Jeffrey Shuren,

Assistant Commissioner for Policy.